Intraocular drainage device

ABSTRACT

An intraocular drainage device may include a monolithic silicone body having a flap, a rigid bottom plate having a portion configured to contact a corresponding portion of the flap, and a tube having a proximal end disposed between the flap and the rigid bottom plate. The corresponding portion of the flap may be configured to separate from the portion of the rigid bottom plate responsive to a fluid pressure in aqueous humor received from the tube. A plurality of parallel microgrooves may be formed on one or more portions of one or more outer surfaces of the intraocular drainage device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 15/828,205 entitled “INTRAOCULAR DRAINAGE DEVICE” filed on Nov. 30,2017, which is a divisional application of U.S. application Ser. No.15/613,021 entitled “INTRAOCULAR DRAINAGE DEVICE” filed Jun. 2, 2017,which claims the benefit of priority under 35 U.S.C. § 119 to U.S.Provisional Patent Application Ser. No. 62/345,723 entitled “INTRAOCULARDRAINAGE DEVICE” filed on Jun. 3, 2016, and U.S. Provisional PatentApplication Ser. No. 62/368,990 entitled “INTRAOCULAR DRAINAGE DEVICEWITH MICROGROOVES” filed on Jul. 29, 2016, the disclosure of each ofwhich is hereby incorporated by reference in its entirety for allpurposes.

TECHNICAL FIELD

The present disclosure generally relates to intraocular devices and, inparticular, relates to intraocular drainage devices.

BACKGROUND

Aqueous humour typically drains from the anterior chamber of the eye viathe trabecular meshwork at the edge of the cornea. However, in somecircumstances, overproduction of aqueous humour or reduced drainage ofaqueous humour can increase intraocular pressure which can causediscomfort and/or damage the optic nerve. Accordingly, it would bedesirable to be able to provide increased drainage of aqueous humourfrom the anterior chamber, particularly for glaucoma patients.

SUMMARY

In accordance with various aspects of the disclosure, an intraoculardrainage device may include a main body, an internal flap, a rigidbottom plate having a portion configured to contact a correspondingportion of the flap, a rigid top plate, and a tube having a proximal enddisposed between the flap and the rigid bottom plate. The main body maybe a rigid main body or a flexible main body. In one implementation thatis sometimes described herein as an example, the main body and the flapmay, for example, be formed from a monolithic silicone body having anintegral flap. However, this is merely illustrative. In otherimplementations, a flexible main body such as a monolithic flexible mainbody may be formed from biocompatible flexible materials other thansilicone. In yet other implementations, the main body may be formed froma rigid material such as a plastic. For example, in someimplementations, the main body, the rigid bottom plate and the rigid topplate may be formed from a common material.

The corresponding portion of the flap may be configured to separate fromthe portion of the rigid bottom plate responsive to a pressure fromaqueous humor received from the tube. The tube can have a distal endconfigured to be extended through the sclera of a patient's eye and intothe anterior chamber of the eye. The silicone body and the rigid bottomplate may form a chamber that is fluidly coupled to a lumen in the tubeso that, in operation, aqueous can flow from the anterior chamber of theeye, through the lumen, to the chamber formed by the silicone body andthe rigid bottom plate.

When aqueous fills the chamber formed by the silicone body and the rigidbottom plate, fluid pressure from the aqueous can bear against thecorresponding portion of the flap causing the corresponding portion ofthe flap to separate from the portion of the rigid bottom plate togenerate a fluid flow path out of the chamber. The fluid flow path mayextend through a channel between the rigid bottom plate and the rigidtop plate and through an opening such as a slot in the silicone body.

The silicone body, the rigid bottom plate, and the rigid top plate maybe coupled together and sutured in place between the sclera and theconjunctiva of the patient's eye. In this configuration, aqueous thatflows out of the fluid flow path through the opening in the siliconebody may diffuse into the patient's tissues surrounding the device.

The chamber formed by the silicone body and the rigid bottom plate maybe disposed between an additional portion of the flap and an additionalcorresponding portion of the rigid bottom plate. The rigid bottom platemay include a first channel adjacent the chamber and a second channel.The first channel may be disposed on a first side of the portion of theflap and the second channel may be disposed on an opposing second sideof the flap to form a portion of the fluid flow path. The rigid topplate may include a channel disposed opposite the second channel of thebottom plate to form a portion of the fluid flow path. The flap mayinclude a recess configured to receive a portion of the tube. Theadditional corresponding portion of the flap may be disposed between theportion of the flap and the recess.

The rigid top plate and rigid bottom plate may be engaged at one or morelocations via one or more corresponding openings in the flap. The rigidbottom plate and/or the rigid top plate may be formed from plastic suchas a polysulfone plastic.

Outer surfaces of the main body, the rigid bottom plate, and/or therigid top plate may be provided with one or more microgrooves. Theintraocular drainage device may include a plurality of microgrooves onone or more outer surfaces of the device. The microgrooves may include aplurality of microgrooves that run in parallel rows from a front portionto a back portion of the device on the top and bottom surfaces of thedevice. The intraocular drainage device may include one or moresubstantially vertical surfaces such as sidewall surfaces connecting thetop and bottom surface. The substantially vertical surfaces may beprovided with one or more parallel microgrooves arranged in rings aroundthe circumference of the device like steps on a ladder.

In some aspects, the microgrooves may be arranged in one or more ofvarious patterns as described herein for contact guidance of cellsand/or tissues surrounding the intraocular device. Contact guidance mayrefer to an in vivo effect described by the Dictionary of Cell andMolecular Biology as “directed locomotory response of cells to ananisotropy of the environment, for example the tendency of fibroblaststo align along ridges or parallel to the alignment of collagen fibres ina stretched gel.”

Although microgrooves on an intraocular implant having a main body, arigid bottom plate, and a rigid top plate, are sometimes describedherein as an example, other intraocular drainage devices can be providedwith microgrooves. For example, microgrooves that extend longitudinallyin a direction from a front of the device to the rear of the device ontop and bottom surfaces, radial microgrooves, circumferential andparallel sidewall microgrooves, and/or other suitable microgroovepatterns for, for example, contact guidance for cell and tissueformation may be provided on the exterior surfaces of intraoculardrainage devices such as those described in U.S. Pat. Nos. 5,411,473,5,616,118, 5,681,275, 5,785,674, 6,261,256, and/or 7,025,740, all ofwhich are incorporated herein by reference in their entireties.

In accordance with some aspects of the subject disclosure, anintraocular drainage device is provided that includes a monolithicsilicone body having a flap, a rigid bottom plate having a portionconfigured to contact a corresponding portion of the flap, and a tubehaving a proximal end disposed between the flap and the rigid bottomplate. The corresponding portion of the flap is configured to separatefrom the portion of the rigid bottom plate responsive to a pressure ofaqueous humor received from the tube.

In accordance with some aspects of the subject disclosure, anintraocular drainage device is provided that includes a main body havinga channel, a flap disposed within the main body, a rigid bottom platehaving a portion configured to contact a corresponding portion of theflap, and a tube bonded to the main body such that the channel isconfigured to guide fluid from the tube to a chamber formed adjacent theflap. The corresponding portion of the flap is configured to separatefrom the portion of the rigid bottom plate responsive to a pressure ofthe fluid in the chamber.

In accordance with some aspects of the subject disclosure, anintraocular drainage device is provided that includes a main body, aflow control device within the main body operable to allow fluid flowthrough the main body in a fluid flow direction, and a plurality ofmicrogrooves formed on an outer surface of the main body, the pluralityof microgrooves being arranged in parallel rows and extendingsubstantially parallel to the fluid flow direction from a front end to aback end of the main body.

In accordance with some aspects of the subject disclosure, anintraocular drainage device is provided that includes a flexible mainbody having a flap and a top surface having an opening bounded byopposing lobes, a rigid bottom plate having a portion configured tocontact a corresponding portion of the flap, and a rigid top platedisposed in the opening in the top surface of the flexible main body. Aportion of the top surface of the rigid top plate in the opening forms aportion of a top surface of the device and the opposing lobes each bearagainst another portion of the top surface of the rigid top plate.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andclaims hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology asclaimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding of the subject technology and are incorporated in andconstitute a part of this description, illustrate aspects of the subjecttechnology and, together with the specification, serve to explainprinciples of the subject technology.

FIG. 1 shows a perspective view of an intraocular drainage device, inaccordance with one or more embodiments of the present disclosure.

FIG. 2 shows an exploded perspective view of the intraocular drainagedevice of FIG. 1, in accordance with one or more embodiments of thepresent disclosure.

FIG. 3 shows a cross-sectional side view of the intraocular drainagedevice of FIG. 1, in accordance with one or more embodiments of thepresent disclosure.

FIG. 4 shows a cross-sectional side view of the intraocular drainagedevice of FIG. 1 in situ in an eye of a patient, in accordance with oneor more embodiments of the present disclosure.

FIG. 5 shows a cross-sectional perspective view of a tube of anintraocular drainage device, in accordance with one or more embodimentsof the present disclosure.

FIG. 6 shows a perspective view of an intraocular drainage device havingmicrogrooves, in accordance with one or more embodiments of the presentdisclosure.

FIG. 7 shows a perspective view of portion of the intraocular drainagedevice having microgrooves of FIG. 6, in accordance with one or moreembodiments of the present disclosure.

FIG. 8 shows a cross-sectional side view of a portion of an implantabledevice having microgrooves, in accordance with one or more embodimentsof the present disclosure.

FIG. 9 shows a top view of an intraocular drainage device, in accordancewith one or more embodiments of the present disclosure.

FIG. 10 shows a perspective view of an intraocular drainage device insitu, in accordance with one or more embodiments of the presentdisclosure.

FIG. 11 shows a side perspective view of an intraocular drainage device,in accordance with one or more embodiments of the present disclosure.

FIG. 12 shows a top perspective view of a top plate for an intraoculardrainage device, in accordance with one or more embodiments of thepresent disclosure.

FIG. 13 shows a bottom perspective view of a top plate for anintraocular drainage device, in accordance with one or more embodimentsof the present disclosure.

FIG. 14 shows a top perspective view of a bottom plate for anintraocular drainage device, in accordance with one or more embodimentsof the present disclosure.

FIG. 15 shows a partially exploded bottom perspective view of anintraocular drainage device, in accordance with one or more embodimentsof the present disclosure.

FIG. 16 shows a bottom perspective view of a main body for anintraocular drainage device, in accordance with one or more embodimentsof the present disclosure.

FIG. 17 shows an exploded top perspective view of an intraoculardrainage device, in accordance with one or more embodiments of thepresent disclosure.

FIG. 18 shows a bottom perspective view of an intraocular drainagedevice, in accordance with one or more embodiments of the presentdisclosure.

DETAILED DESCRIPTION

In the following detailed description, specific details are set forth toprovide an understanding of the subject technology. It will be apparent,however, to one ordinarily skilled in the art that the subjecttechnology may be practiced without some of these specific details. Inother instances, well-known structures and techniques have not beenshown in detail so as not to obscure the subject technology.

According to some embodiments, for example as shown in FIG. 1, anintraocular device such as intraocular drainage device 100 can include amain body 102 such as a relatively flexible main body and a relativelyrigid top plate 108 disposed in an opening in a top surface of the mainbody. Although various examples are described herein in which main body102 is a flexible main body (e.g., a silicone body or a flexible mainbody formed from other biocompatible flexible materials), otherimplementations with a rigid main body 102 are contemplated. Flexiblemain body 102 may include an outlet port 104. Intraocular drainagedevice 100 may also include an input tube 106 having a lumen (notvisible in FIG. 1). A valve within flexible main body 102 may beoperable to controllably couple the lumen of tube 106 with an outletport such as outlet port 104 located at or near a back end 158 of mainbody 102.

Rigid top plate 108 may be formed, for example, from a rigid plasticsuch as polysulfone plastic. Flexible main body 102 may be a monolithicflexible body formed, for example, from silicone or other suitableflexible materials. In the example of FIG. 1, outlet port 104 is formedfrom slot in the top surface of main body 102 adjacent top plate 108.However, this is merely illustrative. In other embodiments, outlet port104 may be a round, square, oval, multi-leaf, v-shaped, or other-shapedopening in flexible body 102 and/or may be formed at other locations(e.g., spaced apart from top plate 108 or partially or completelydisposed on an edge of main body 102. In other embodiments, more thanone outlet port may be formed in main body 102 and/or other componentsof device 100 such as top plate 108.

As shown in FIG. 1, main body 102 may include a pair of extensions suchas arms 110 that extend along opposing sides of a portion of tube 106.Arms 110 may be configured to extend from main body 102, at the frontend 160 of main body 102, in the direction of the anterior of apatient's eye. Each arm 110 may include one or more features thatfacilitate securement of device 100 to the eye of the patient. In theexample of FIG. 1, each arm 110 includes an opening 112 for suturing ofmain body 102 to the patient's eye. Each arm 110 may have a thicknessthat is substantially the same as the thickness of tube 106. Extendingarms 110 may allow suturing of device 100 at a location closer to thelimbus of the eye than in conventional devices which may facilitateeasier implantation for a surgeon.

Intraocular device 100 may be surgically implanted between the scleraand the conjunctiva of the eye of a patient such that fluid such asaqueous humor that flows through device 100 (e.g., in a fluid flowdirection as indicated by arrow 156) and out from outlet port 104 formsa bleb on and/or around the outer surface of device 100 that can beabsorbed the surrounding tissue (e.g., via the scleral venous system).The outer surface of device 100 may include a top surface 150 of mainbody 102, a top surface 154 of top plate 108, and a sidewall surface 152of main body 102 that extends between top surface 150 and a bottomsurface (not visible in FIG. 1) of main body 102. The outer surface ofdevice 100 may also include the bottom surface of main body 102 and abottom surface of a bottom plate (not visible in FIG. 1) disposed in anopening in the bottom surface of main body 102. As discussed in furtherdetail hereinafter, following implantation, intraocular device 100 maybe configured such that the bottom surface of main body and the bottomsurface of the bottom plate rest against the sclera of the patient's eyeand such that the top surface 150 of main body 102 and the top surface154 of top plate 108 rest against the conjunctiva of the patient's eye.As discussed in further detail below in connection with, for example,FIGS. 6 and 7, one or more portions of the outer surface of device 100may include microgroove patterns that aid the healing response of theeye and may also improve the functioning of the device over timefollowing implantation.

Tube 106 may be fluidly coupled, at a proximal end (e.g., proximal tomain body 102 relative to a distal end of the tube), to a chamber withinmain body 102. As shown in FIG. 1, tube 106 may extend from a front end160 of main body 102 at a location between arms 110 toward the anteriorof the patient's eye. A distal end of tube 106 may be configured to bedisposed within an anterior chamber of the eye of a patient so thatfluid such as aqueous humor can enter a lumen of the tube 114 andcontrollably flow through the lumen to the chamber. A portion of tube106 is configured to extend through a portion of the sclera of the eyeof the patient at a location between the proximal end and the distal endso that the distal end of tube 106 can reach the anterior chamber.

In some embodiments, device 100 may be provided with a removable cannulathat can be used for flushing of device 100 prior to surgicalimplantation.

Turning now to the exploded perspective view of device 100 in FIG. 2,features of main body 102 and a rigid bottom plate 200 that form achamber and a valve to control fluid flow from tube 106 to outlet port104 can be seen. For example, main body 102 may include a flap 214 thatextends laterally across the interior of main body 102. In an assembledconfiguration for device 100 (e.g., the assembled configuration shown inFIG. 1), flap 214 may be configured to seat against a top or interiorsurface 220 of bottom plate 200 to form a valve with a disengageableseal. Flap 214 may be a silicone flap having a thickness of less thanabout one five-thousandth of an inch (for example).

In the assembled configuration, tube 106 may extend at least partiallyinto a channel 208 in bottom plate 200. A top surface of tube 106 mayseat at least partially within a recess 222 of main body 102. In thisway, tube 106 may be secured within channel 208 (e.g., by a sealingcompression caused by top plate 108 and bottom plate 200) such that thelumen of the tube is in fluid communication with a chamber formed by aportion of channel 208 and flap 214. However, this is merelyillustrative.

In other implementations, tube 106 may be bonded to main body 102. Inthis implementation, main body 102 may have a channel therewithinconfigured guide fluid from tube 106 to a chamber such as chamber 304under flap 214.

In various implementations, the portion of flap 214 that seats againsttop surface 220 of bottom plate 200 may separate from surface 220responsive to a pressure of aqueous humor received in the chamber,thereby allowing aqueous to flow between flap 214 and top surface 220.

Bottom plate 200 may include an additional channel 202 formed betweenridges 206. Channel 202 of bottom plate 200 may, in an assembledconfiguration, be disposed opposite a corresponding channel 204 of topplate 108. Channel 204 of top plate 108 may be formed between ridges207. Ridges 207 of top plate 108 may engage with ridges 206 of bottomplate 200 within an internal opening 212 within main body 102. Forexample, during assembly of device 100, top plate 108 may be placed intoan opening 210 in a top surface of main body 102 and bottom plate 200may be placed into an opening in a bottom surface of main body 102 suchthat ridges 206 of bottom plate 200 and ridges 207 of top plate 108 meetwithin opening 212 proximal to flap 214. Ridges 207 of top plate 108 andridges 206 of bottom plate 200 may be secured together mechanically,adhesively, or may be ultrasonically welded together (for example) tosecure top plate 108 to bottom plate 200 with flap 214 securedtherebetween.

Additional portions of top plate 108 and bottom plate 200 may be engagedtogether (e.g., mechanically, adhesively, or using an ultrasonic weld)within additional internal openings in main body 102 such as openings216 and 218, each disposed on a distal side of flap 214. Bottom plate200 may be formed, for example, from a rigid plastic such as polysulfoneplastic.

During assembly operations for device 100, tube 106 may be providedbetween bottom plate 200 (e.g., within a portion of channel 208) andrecess 222 of main body 102 such that, when top plate 108 and bottomplate 200 are secured together, tube 106 is secured between bottom plate200 and main body 102. Opposing channels 202 and 204 may form an exitport within device 100 that is fluidly coupled with outlet port 104.

FIG. 3 shows a cross-sectional side view of intraocular device 100 inwhich various additional features of device 100 can be seen. Forexample, as shown in FIG. 3, tube 106 may include a lumen 300 in fluidcommunication with a chamber 304 formed between a portion of bottomplate 200 and flap 214 (e.g., within a portion of channel 208 of FIG.2). In operation, when fluid pressure within chamber 304 (e.g., due toaqueous humor received from the anterior chamber of a patient's eye vialumen 300) reaches a predetermined pressure threshold, the portion offlap 214 that is seated against bottom plate 200 may be moved away frombottom plate 200 to allow fluid to flow therebetween to an exit port 306formed between top plate 108 and bottom plate 200 (e.g., by opposingchannels 202 and 204 of FIG. 2).

In the example of FIG. 3, an additional chamber 302 is shown between atop surface of flap 214 and a bottom or interior surface of top plate108. Chamber 302 may provide space into which flap 214 can move whendisplaced from bottom plate 200 by fluid pressure in chamber 304.Chamber 302 may be in fluid communication with exit port 306 such thatfluid that flows from exit port 306 can flow out of device 100 throughoutlet port 104 and/or into chamber 302. However, this is merelyillustrative. In other implementations, chamber 302 may be preventedfrom receiving fluid that flows between flap 214 and bottom plate 200from chamber 304 and/or prevented from receiving any fluid from outsideof device 100 (e.g., via outlet port 104.

For example, in FIG. 3, a proximal end of flap 214 is shown spaced apartfrom the exit port 306 formed by channels 202 and 204. However, in otherimplementations, the proximal end of flap 214 may extend to or partiallyinto the exit port 306 formed by channels 202 and 204 such that flap 214itself blocks fluid flow into chamber 302 while still allowing fluidflow out of chamber 304 to outlet port 104 when flap 214 is displacedfrom bottom plate 200. In other implementations, additional flow controlstructures may be provided that block flow of fluids into chamber 302.

It can also be seen in FIG. 3 that main body 102 may be a monolithic(e.g., molded) body in which flap 214 is integrally and continuouslyformed with other portions of the main body. However, this is merelyillustrative. In other configurations, flap 214 may be a separate flapformed within main body 102.

As shown in the example of FIG. 3, in the assembled configuration,bottom plate 200 and the bottom surface of main body 102 may form abottom concave surface 310 for device 100 having a shape configured toconform to the convex shape of the sclera of the patient's eye. Bottomconcave surface 310 may be formed by bottom surface 350 of main body 102and bottom surface 352 of bottom plate 200. In the assembledconfiguration, top plate 108 and the top surface of main body 102 mayform a top convex surface 312 for device 100 having a shape configuredto conform to the concave interior shape of the conjunctiva of thepatient's eye.

FIG. 4 schematically shows a cross-sectional view of intraoculardrainage device 100 disposed in situ in a patient's eye such that mainbody 102, assembled with top and bottom plates 108 and 200 is disposedbetween the sclera 400 and conjunctiva 402 of the patient's eye. Asshown, tube 106 may extend through sclera 400 so that aqueous humor 403in the anterior chamber 401 of the eye (bounded in part by cornea 406,lens 404 and iris 408) can flow into the lumen of tube 106 (as indicatedby arrow 410).

As shown in FIG. 4, fluid that has flowed through the valve formedwithin device 100 by flap 214 and bottom plate 200 may form a bleb 412on and/or around device 100 that can be absorbed into the patient'stissue. In this way, excess fluid pressure in anterior chamber 401associated with a glaucoma condition may be relieved.

FIG. 5 is a cross-sectional perspective view of a portion of tube 106.In the example of FIG. 5, tube 106 has a D-shaped cross-sectionalprofile. A D-shaped cross-sectional profile may provide archways 502along sidewalls 500 of lumen 300 that prevent kinking or crushing oflumen 300.

Moreover, the D-shaped profile of tube 106 may provide a relatively flatbottom surface 504 of tube 106 for resting against the sclera of thepatient's eye and may provide a top surface 506 having a relativelylarge radius of curvature (e.g., relative to the radius of curvature ofa cylindrical tube) that reduces the stress point at which theconjunctiva of the eye interfaces with tube 106. A relatively flatbottom surface 504 and a relatively large radius of curvature topsurface 506 may reduce the stress on the underlying sclera and theoverlaying conjunctiva due to the presence of tube 106 and may provide asubstantially thinner tube (e.g., a tube with a thickness of less thanabout 20 thousandths of an inch or between 12 and 16 thousandths of aninch). Lumen 300 may have a bottom surface 509 that is substantiallyflat and substantially parallel to bottom surface 504. Lumen 300 mayhave a top surface 511 having a radius of curvature that corresponds tothe radius of curvature of top surface 506 so that top surface 511 andtop surface 506 are substantially parallel. Top surface 511 and bottomsurface 509 of lumen 300 each run between sidewalls 500.

A low profile tube such as the D-shaped tube of FIG. 5 may help reduceor eliminate the need for a graft of a patch of tissue over tube 106that protects the conjunctiva. However, this is merely illustrative andtube 106 may be covered with patch graft in some scenarios.

In some implementations, one or more portions of one or more outersurfaces of an intraocular drainage device may be provided with one ormore grooves such as microgrooves. In some implanted medical devices,surface patterning can be used to enhance, or prevent, cell or bacterialattachment to the implanted device. For example, in some devices aSharklet™ pattern can be used to deter bacterial growth.

However, in some embodiments disclosed herein, microgroove patterns suchas parallel front-to-back top and bottom surface patterns, radialpatterns, circumferential sidewall patterns and/or other suitablemicrogroove patterns may be provided, not to prevent attachment with asurface, but to help organize cells into a controlled alignment alongthe implant. For example, the micro-grooves may align rows of cellsalong the microgrooves and/or align individual cells (e.g., by causingelongation of an individual cell and/or individual cell nucleus) alongthe microgrooves. For example, the microgrooves may facilitate contactguidance and/or other effects that cause alignment of the rows of cellsor individual cells.

FIG. 6 shows exemplary microgrooves that may be formed on intraoculardrainage device 100 as described herein, in accordance with someembodiments. However, it should be noted that FIG. 6 is merelyillustrative and microgroove patterns as described herein can beprovided on the outer surfaces of other intraocular drainage devices andother implants.

As shown in FIG. 6, intraocular drainage device 100 may include one ormore microgrooves 602 that extend along the top surface of device 100along the direction 156 (see FIG. 1) of fluid flow within the devicefrom front end 160 toward back end 158. Microgrooves 602 may run inparallel rows along the top surface of device 100. In the example ofFIG. 6, two parallel microgrooves are shown on the top surface. However,this is merely illustrative. In other implementations, one, two, three,four, tens, hundreds, or thousands of microgrooves 602 may be formed inparallel rows that substantially cover the entire top surface of device100.

Circumferential grooves 600 may also be formed on a sidewall of device100 (e.g., on sidewall 152 of main body 102). Although circumferentialgrooves 600 are shown extending around only a portion of thecircumference of sidewall 152, this is merely illustrative. In variousembodiments, grooves 600 may extend around substantially the entirecircumference of main body 102 or any portion thereof.

In the example of FIG. 6, three parallel microgrooves 600 are shown onthe sidewall surface. However, this is merely illustrative. In otherimplementations, microgrooves 600 may be formed in parallel rows thatsubstantially cover the entire sidewall surface of device 100.

As shown in FIG. 6, microgrooves 602 may include a portion 604 that runsalong the top surface 154 of top plate 108 in some embodiments. Forexample, portion 604 of microgrooves 602 may be formed such that asubset of microgrooves 602 each includes front and back groove portionsformed on surface 150 of main body 102 and includes a portion formed ontop surface 154 that extends between the front and back groove portionson surface 150 to form a substantially continuous groove across themultiple components (e.g., across main body 102 and top plate 108).

Although bottom surface 350 of main body 102 and bottom surface 352 ofbottom plate 200 (see, e.g., FIG. 3) are not shown in FIG. 6, it shouldbe appreciated that bottom surface 310 may also include one or moremicrogrooves that extend along the bottom surface 310 of device 100along the direction 156 (see FIG. 1) of fluid flow from front end 160toward back end 158. Microgrooves on bottom surface 310 may run inparallel rows along the bottom surface 310 of device 100.

Microgrooves formed on bottom surface 310 may include a portion thatruns along the bottom surface 352 of bottom plate 200 in someembodiments. For example, a portion of the microgrooves on bottomsurface 310 may be formed such that a subset of the bottom surfacemicrogrooves each includes front and back portions formed on surface 350of main body 102 and includes a portion formed on bottom surface 352that extends between the front and back portions on surface 350 to forma substantially continuous groove across the multiple components (e.g.,main body 102 and bottom plate 200).

FIG. 7 shows an enlarged view of a portion of main body 102 showingmicrogrooves 600 and 602 formed thereon. In the example of FIG. 7,microgrooves 600 and 602 each only cover a portion of respective topsurface 150 and sidewall surface 152, however this is merelyillustrative. In other implementations, microgrooves 600 and 602, alongwith microgrooves formed on bottom surface 310, may cover substantiallyall of the outer surface of device 100 (including substantially all ofthe outer surface of main body 102 and, if desired, tube 106 includingsome or all of top surface 506 and bottom surface 504 of tube 106).

As shown in FIG. 7, microgrooves such as microgrooves 600 and 602 may beformed in equally-spaced rows of microgrooves. Each microgroove may havea width, a depth, and a separation from an adjacent microgroove, each ofapproximately between 10 and 40 microns (e.g., a width, a depth, and aseparation each substantially equal to 25 microns in oneimplementation). As shown in FIG. 7, in some embodiments,circumferential grooves 600 on sidewall 152 may be formed in sets 700 ofmicrogrooves, the sets 700 being separated by a gap 702 within which thesurface of sidewall 152 is substantially smooth.

Because, in situ, sidewall 152 may be arranged substantially verticallywith respect to the surface of the patient's eye (e.g., the scleralsurface), the circumferential arrangement of grooves 600 shown in FIG. 7may help to prevent travel of patient cells downward along the sidewallsurface toward the eyeball. As shown in FIG. 7, a substantially smoothgap 704 may be provided between grooves 600 and 602 in someimplementations.

FIG. 8 shows an exemplary cross-sectional side view of microgrooves 800formed on an outer surface of an implantable device 802 (e.g., animplementation of intraocular drainage device 100). Microgrooves 800 maybe formed, for example, by laser patterning the surface of a component.In the example of FIG. 8, microgrooves 800 each have a depth of 25microns, a width at an upper edge of 25 microns and a spacing of 17microns. However, this is merely illustrative. As previously noted, eachmicrogroove may have a width, a depth, and a separation from an adjacentmicrogroove, each of approximately between 10 and 40 microns. In theexample, of FIG. 8, microgrooves 800 have angled (e.g., non-parallel)sidewalls that converge in a substantially concave bottom surface.However, this is merely illustrative. In other implementations,microgrooves may have parallel sidewalls, planar bottom surfaces, convexor concave sidewalls, a convex bottom surface or any combination thereof(as examples).

Microgrooves on an intraocular drainage device as described herein inconnection with various embodiments and implementations may improveorganization of fibroblasts and decrease fibrosis for implanted devices,which may help prevent, for example, encapsulation of the implanteddevice that could otherwise prevent absorption of aqueous around thedevice, thereby reducing the lifetime and/or effectiveness of thedevice.

Although various examples of intraocular drainage device 100 have beendescribed in which top plate 108 is disposed in an opening 210 in mainbody 102 that has a size and shape that match the size and shape of topplate 108, this is merely illustrative. In various implementations, topplate 108 may be inserted into an opening in main body 102 that issmaller than top plate 108. FIGS. 9 and 10 show exemplary views of anintraocular drainage device 100 having a top plate 108 disposed withinan opening in a main body 102, the opening being smaller than the sizeof the top plate.

As shown in FIG. 9, in an assembled configuration, intraocular drainagedevice 100 may have a top plate 108 that is secured within a recess inmain body 102 by lobes 900 of the main body that extend over a portionof the top surface of the top plate. Opening 901, having a size that issmaller than the size of top plate 108, may be resiliently stretchableto allow top plate 108 to be inserted through opening 901. Lobes 900 mayhelp secure top plate 108 within main body 102.

FIG. 10 shows an example of the intraocular drainage device 100 of FIG.10 in situ on the sclera 400 of a patient's eye with tube 106 extendingthrough the sclera into the anterior chamber of the eye behind thecornea 406. In the perspective view of FIG. 10, it can be seen that onlya portion 154′ of the top surface of top plate 108 is exposed withinopening 901 in main body 102 while other portions of the top surface arecovered by lobes 900. Lobes 900 may bear against the other portions ofthe top surface of top plate 108.

The top view of FIGS. 9 and 10 also show how each of arms 110 of mainbody 102 may be extend along and be separated from tube 106 by a gap902. In this way, suture openings 112 may be formed nearer to the cornea406 of the eye and arms 110 may be flexibly movable to conform to thefeatures of the surface of the sclera 400. Conjunctival tissue that maybe formed over device 100 in situ is not shown in FIG. 10 for clarity.

FIG. 11 shows a side perspective view of the intraocular drainage device100 of FIGS. 9 and 10 in which the convex top surface 312, formed bylobes 900, portion 154′ of top plate 108, and shelf 1102 of main body102, can be seen. In the examples of FIGS. 9-11, main body 102 includesstep 1100 between shelf 1102 and lobes 900.

As shown in FIG. 12, in some implementations, top plate 108 may beimplemented with a step 1210 that fits into the step 1100 in main body102. In the example of FIG. 12, top plate 108 also includes shelfmembers 1202 disposed on opposing sides of a central portion 1200. Shelfmembers 1202 may be disposed underneath corresponding portions of shelf1102 of FIG. 11 in an assembled configuration of device 100. As shown,shelf members 1202 may be separated by a gap 1204 at a front end of topplate 108 and by a gap 1208 at a rear end of top plate 108. Gap 1204 maybe larger than gap 1208. Gap 1204 may accommodate a portion of tube 106.Gap 1208 may allow fluid (e.g., aqueous humour) to flow therethrough.

FIG. 13 is a bottom view of top plate 108 of FIG. 12. As shown in FIG.13, a recess 1300 may be formed between shelf members 1202 on theunderside of top plate 108. Various structural features may be formed onthe underside of top plate 108 within recess 1300. As shown in FIG. 13,the structural features may include ridges 1306 configured to beattached (e.g., ultrasonically welded) to bottom plate 200 to attach topplate 108 to bottom plate 200. The structural features may also includea channel 1302 configured to receive a corresponding feature 222 of mainbody 102 within which a portion of tube 106 is disposed in an assembledconfiguration. The structural features may also include a widenedchannel 1304, which may form at least a portion of chamber 302 intowhich flap 214 can be raised by aqueous humor below the flap. Thestructural features may also include ridges 1308 that help to secure andcontrol the raising of flap 214.

FIG. 14 shows a top perspective view of bottom plate 200 in animplementation that may be used, for example, with top plate 108 ofFIGS. 9-13. As shown in FIG. 14, top surface 1400 of bottom plate 200may be substantially free of ridges such as ridges 206 of FIG. 2. Insuch an implementation, ridges 1306 of top plate 108 may be attacheddirectly to surface 1400 to secure top plate 108 to bottom plate 200. Inan assembled configuration for intraocular drainage device 100, flap 214may bear against surface 1400 until fluid pressure from aqueous humorfrom tube 106 raises the flap to separate the flap from surface 1400 toallow the aqueous humour to flow between surface 1400 and flap 214. Asshown in FIG. 14, channel 208 may include a first portion havingsubstantially parallel sidewalls 1402 and configured to receive aportion of tube 106. Channel 208 may also include an expanded portion1410 formed by sidewalls 1404 that run away from each other on opposingsides of channel 208 in a curve that connects to additionalsubstantially parallel portions 1406 spaced further apart than parallelsidewalls 1402. Substantially parallel portions 1406 of the sidewalls ofexpanded portions 1406 may meet with a transverse sidewall 1408 thatruns between sidewalls 1406 substantially linearly in a directionperpendicular to sidewalls 1406. Sidewalls 1402 may be substantiallyplanar sidewalls formed at a substantially perpendicular angle tosurface 1400 or may be concave sidewalls having a shape that conforms tothe shape of a portion of tube 106. Sidewalls 1404 and 1406 may becurved sidewalls as shown.

Expanded portion 1410 may form chamber 304 (see, e.g., FIG. 3) beneathflap 214. When fluid pressure within chamber 304 (e.g., due to aqueoushumor received in expanded portion 1410 of channel 208 from the anteriorchamber of a patient's eye via lumen 300) reaches a predeterminedpressure threshold, the portion of flap 214 that is seated againstsurface 1400 of bottom plate 200 may be moved away from bottom plate 200to allow fluid to flow therebetween. Providing a channel 208 with anexpanded portion 1410 may provide a larger surface area on flap 214 forthe fluid to bear against to lift the flap to allow fluid flow.

Concave bottom surface 352 of bottom plate 200 of FIG. 14 can be seen inthe partially exploded perspective view of intraocular drainage device100 in FIG. 15. As shown, concave bottom surface 352 of bottom plate 200and concave bottom surface 350 of main body 102 may form a concavebottom surface for intraocular drainage device 100 when bottom plate 200is placed into opening 1510 in the bottom surface of main body 102 andbonded to top plate 108.

As shown in FIG. 15, ridges 1306 on top plate 108 extend throughopenings in flap 214 so that they can mate with surface 1400 of bottomplate 200 when bottom plate 200 is inserted into opening 1510. FIG. 15also shows a channel 1502 in main body 102 that extends from a gap 1500between arms 110 continuously to recess 222 for receiving tube 106.

FIG. 16 shows an enlarged bottom perspective view of main body 102 inwhich openings 212, 216 and 218, through which ridges 1306 can pass, canbe seen. Opening 212 may also form a portion of a fluid pathway foraqueous humor when flap 214 is raised away from surface 1400 of bottomplate 200.

FIG. 17 shows a top exploded perspective view of intraocular drainagedevice 100 in accordance with various aspects. In the example of FIG.17, top plate 108 of FIGS. 12 and 13 and bottom plate 200 of FIG. 14 areimplemented with a main body 102 having an opening 901 that is smallerthan the size of top plate 108. To assemble intraocular drainage device100, top plate 108 is inserted into opening 901 and positioned such thatshelf members 1202 and step 1210 of top plate 108 are disposed againstcorresponding shelf portions 1102 and step 1100 of main body 102 andsuch that ridges 1306 of top plate 108 extend through openings 212, 216and 218 in flap 214. Tube 106 is placed into recess 1502 and 222 in mainbody 102 and bottom plate 200 is placed into opening 1510 in main body102 such that surface 1400 of bottom plate 200 abuts ridges 1306. Ridges1306 are then bonded (e.g., adhesively bonded, mechanically bonded, orultrasonically welded) to surface 1400 of bottom plate 200 to secure topplate 108 to bottom plate 200 and thereby secure main body 102, flap214, and tube 106 between top plate 108 and bottom plate 200. Topsurface 1700 may be lifted into recess 1304 of top plate 108 by pressuregenerated by aqueous humour from tube 106.

A bottom perspective view of a fully assembled intraocular drainagedevice 100 is shown in FIG. 18 in accordance with some aspects of thesubject disclosure. As shown in FIG. 18, the bottom surface ofintraocular drainage device 100 is shaped and arranged to conform to thesclera of a patient's eye in situ. In particular, the concave bottomsurface 350 of main body 102 and the concave bottom surface 352 ofbottom plate 200 cooperate to form a substantially continuous concavebottom surface for intraocular drainage device 100 in which main body102 is flexible to conform to the surface of the sclera. Additionally,as shown in FIG. 18, tube 106 may have a substantially flat bottomsurface 504 that provides an increased surface area of contact with theunderlying sclera of the eye and reduces the contact pressure relativeto a round bottomed tube.

As noted above in connection with, for example, FIGS. 6-8, the outersurfaces of intraocular drainage device 100 may include microgrooves.Microgrooves may be formed, for example, on portion 154′ of the topsurface of top plate 108 of FIGS. 9-13. Microgrooves may be formed onbottom surfaces 350 and 352 of main body 102 and bottom plate 200.Microgrooves may be formed on a main body 102 having an opening 210 thatis sized and configured to match the size and shape of top plate 108 oron a main body 102 having an opening 901 and lobes 900 in an arrangementas described above in connection with FIGS. 7 and 8. Microgrooves may beformed on shelf portion 1102, step 1100, lobes 900 and/or any othersurface such as sidewall surfaces of main body 102 (e.g., as describedabove in connection with FIGS. 7 and 8).

The subject technology is illustrated, for example, according to variousaspects described above. Various examples of these aspects are describedas numbered concepts or clauses (1, 2, 3, etc.) for convenience. Theseconcepts or clauses are provided as examples and do not limit thesubject technology. It is noted that any of the dependent concepts maybe combined in any combination with each other or one or more otherindependent concepts, to form an independent concept. The following is anon-limiting summary of some concepts presented herein:

Concept 1. An intraocular drainage device, comprising:

a monolithic silicone body having a flap;

a rigid bottom plate having a portion configured to contact acorresponding portion of the flap; and

a tube having a proximal end disposed between the flap and the rigidbottom plate, wherein the corresponding portion of the flap isconfigured to separate from the portion of the rigid bottom plateresponsive to a pressure of aqueous humor received from the tube.

Concept 2. The intraocular drainage device of Concept 1 or any otherConcept, wherein the tube comprises a distal end configured to bedisposed within an anterior chamber of an eye of a patient.

Concept 3. The intraocular drainage device of Concept 2 or any otherConcept, wherein the tube is configured to extend through a portion of asclera of the eye of the patient at a location between the proximal endand the distal end.

Concept 4. The intraocular drainage device of Concept 1 or any otherConcept, further comprising a chamber disposed between an additionalportion of the flap and an additional corresponding portion of the rigidbottom plate.

Concept 5. The intraocular drainage device of Concept 4 or any otherConcept, wherein a lumen of the tube is fluidly coupled to the chamberat the proximal end.

Concept 6. The intraocular drainage device of Concept 5 or any otherConcept, wherein the rigid bottom plate comprises a first channeladjacent the chamber.

Concept 7. The intraocular drainage device of Concept 6 or any otherConcept, wherein the flap comprises a recess configured to receive aportion of the tube.

Concept 8. The intraocular drainage device of Concept 7 or any otherConcept, wherein the additional corresponding portion of the flapdefines a portion of the chamber and is disposed between the portion ofthe flap that contacts the rigid bottom plate and the recess.

Concept 9. The intraocular drainage device of Concept 8 or any otherConcept, wherein the rigid bottom plate comprises a second channel,wherein the first channel is disposed on a first side of the portion ofthe flap and wherein the second channel is disposed on an opposingsecond side of the flap.

Concept 10. The intraocular drainage device of Concept 9 or any otherConcept, further comprising a rigid top plate.

Concept 11. The intraocular drainage device of Concept 10 or any otherConcept, wherein the rigid top plate comprises a channel disposedopposite the second channel of the bottom plate.

Concept 12. The intraocular drainage device of Concept 11 or any otherConcept, wherein the monolithic silicone body comprises an openingadjacent an exit port, the exit port formed by the channel of the topplate and the opposing second channel of the bottom plate.

Concept 13. The intraocular drainage device of Concept 12 or any otherConcept, wherein the opening comprises a slot.

Concept 14. The intraocular drainage device of Concept 1 or any otherConcept, wherein the tube has a D-shaped cross-sectional profile.

Concept 15. The intraocular drainage device of Concept 14 or any otherConcept, wherein tube comprises a lumen that has a correspondingD-shaped cross-sectional profile.

Concept 16. The intraocular drainage device of Concept 1 or any otherConcept, further comprising a rigid top plate.

Concept 17. The intraocular drainage device of Concept 16 or any otherConcept, wherein the rigid bottom plate is sealingly disposed within anopening in a bottom surface of the monolithic silicone body.

Concept 18. The intraocular drainage device of Concept 17 or any otherConcept, wherein the rigid top plate is sealingly disposed within anopening in a top surface of the monolithic silicone body.

Concept 19. The intraocular drainage device of Concept 18 or any otherConcept, wherein the rigid top plate and rigid bottom plate engaged atone or more locations via one or more corresponding openings in theflap.

Concept 20. The intraocular drainage device of Concept 16 or any otherConcept, wherein the rigid bottom plate is plastic.

Concept 21. The intraocular drainage device of Concept 20 or any otherConcept, wherein the rigid top plate is plastic.

Concept 22. The intraocular drainage device of Concept 21 or any otherConcept, wherein the plastic comprises polysulfone.

Concept 23. The intraocular drainage device of Concept 1 or any otherConcept, further comprising a plurality of parallel microgrooves on atleast a portion of an outer surface of the monolithic silicone body.

Concept 24. The intraocular drainage device of Concept 23 or any otherConcept, further comprising a plurality of microgrooves on the rigidbottom plate.

Concept 25. The intraocular drainage device of Concept 24 or any otherConcept, further comprising:

a rigid top plate disposed in an opening in the monolithic siliconebody; and

a plurality of microgrooves on the rigid top plate.

Concept 26. The intraocular drainage device of Concept 23 or any otherConcept, wherein the plurality of parallel microgrooves comprisesparallel microgrooves formed on a top surface, a bottom surface, and asidewall surface of the monolithic silicone body.

Concept 27. An intraocular drainage device, comprising:

a main body having a channel;

a flap disposed within the main body;

a rigid bottom plate having a portion configured to contact acorresponding portion of the flap; and

a tube bonded to the main body such that the channel is configured toguide fluid from the tube to a chamber formed adjacent the flap, whereinthe corresponding portion of the flap is configured to separate from theportion of the rigid bottom plate responsive to a pressure of the fluidin the chamber.

Concept 28. An intraocular drainage device, comprising:

a main body;

a flow control device within the main body operable to allow fluid flowthrough the main body in a fluid flow direction; and

a plurality of microgrooves formed on an outer surface of the main body,the plurality of microgrooves being arranged in parallel rows andextending substantially parallel to the fluid flow direction from afront end to a back end of the main body.

Concept 29. The intraocular drainage device of Concept 28 or any otherConcept, wherein the plurality of microgrooves include parallel rows ofmicrogrooves on a top surface of the main body.

Concept 30. The intraocular drainage device of Concept 29 or any otherConcept, wherein the plurality of microgrooves further include parallelrows of microgrooves on a bottom surface of the main body.

Concept 31. The intraocular drainage device of Concept 30 or any otherConcept, wherein the plurality of microgrooves further include parallelrows of microgrooves on a sidewall surface of the main body.

Concept 32. The intraocular drainage device of Concept 31 or any otherConcept, wherein the parallel rows of microgrooves on the sidewallsurface of the main body comprise circumferential microgrooves thatextend around at least a portion of the circumference of the main body.

Concept 33. The intraocular drainage device of Concept 28 or any otherConcept, wherein the parallel rows of microgrooves are each separated byapproximately 25 microns.

Concept 34. The intraocular drainage device of Concept 28 or any otherConcept, wherein the main body comprises a flexible main body, whereinthe flow control device comprises a valve formed in part by a flapportion of the flexible main body, and wherein the device furthercomprises:

a rigid top plate and a rigid bottom plate each disposed in a respectiveopening on the flexible main body; and

a plurality of microgrooves extending substantially parallel to thefluid flow direction on each of the rigid top plate and the rigid bottomplate.

Concept 35. An intraocular drainage device, comprising:

a flexible main body having a flap and a top surface having an openingbounded by opposing lobes;

a rigid bottom plate having a portion configured to contact acorresponding portion of the flap; and

a rigid top plate disposed in the opening in the top surface of theflexible main body, wherein a portion of the top surface of the rigidtop plate in the opening forms a portion of a top surface of the deviceand wherein the opposing lobes each bear against another portion of thetop surface of the rigid top plate.

Concept 36. The intraocular drainage device of Concept 35 or any otherConcept, wherein the rigid top plate comprises a central portion and apair of shelf members disposed on opposing sides of the rigid top plate.

Concept 37. The intraocular drainage device of Concept 36 or any otherConcept, wherein the rigid top plate comprises a step disposed betweenthe pair of shelf members and the top surface of the rigid top plate andwherein the flexible main body includes a step that conforms to the stepon the rigid top plate.

Concept 38. The intraocular drainage device of Concept 35 or any otherConcept, further comprising a tube having a proximal end disposedbetween the flap and the rigid bottom plate, wherein the correspondingportion of the flap is configured to separate from the portion of therigid bottom plate responsive to a pressure of aqueous humor receivedfrom the tube.

Concept 39. The intraocular drainage device of Concept 38 or any otherConcept, wherein the tube comprises a distal end configured to bedisposed within an anterior chamber of an eye of a patient.

Concept 40. The intraocular drainage device of Concept 35 or any otherConcept, wherein the flexible main body comprises a monolithic siliconebody.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. Any accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

A phrase such as “an aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples of the disclosure. A phrasesuch as “an aspect” may refer to one or more aspects and vice versa. Aphrase such as “an embodiment” does not imply that such embodiment isessential to the subject technology or that such embodiment applies toall configurations of the subject technology. A disclosure relating toan embodiment may apply to all embodiments, or one or more embodiments.An embodiment may provide one or more examples of the disclosure. Aphrase such “an embodiment” may refer to one or more embodiments andvice versa. A phrase such as “a configuration” does not imply that suchconfiguration is essential to the subject technology or that suchconfiguration applies to all configurations of the subject technology. Adisclosure relating to a configuration may apply to all configurations,or one or more configurations. A configuration may provide one or moreexamples of the disclosure. A phrase such as “a configuration” may referto one or more configurations and vice versa.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (i.e.,each item). The phrase “at least one of” does not require selection ofat least one of each item listed; rather, the phrase allows a meaningthat includes at least one of any one of the items, and/or at least oneof any combination of the items, and/or at least one of each of theitems. By way of example, the phrases “at least one of A, B, and C” or“at least one of A, B, or C” each refer to only A, only B, or only C;any combination of A, B, and C; and/or at least one of each of A, B, andC.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.”Pronouns in the masculine (e.g., his) include the feminine and neutergender (e.g., her and its) and vice versa. The term “some” refers to oneor more. Underlined and/or italicized headings and subheadings are usedfor convenience only, do not limit the subject technology, and are notreferred to in connection with the interpretation of the description ofthe subject technology. All structural and functional equivalents to theelements of the various configurations described throughout thisdisclosure that are known or later come to be known to those of ordinaryskill in the art are expressly incorporated herein by reference andintended to be encompassed by the subject technology. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the above description.

While certain aspects and embodiments of the subject technology havebeen described, these have been presented by way of example only, andare not intended to limit the scope of the subject technology. Indeed,the novel methods and systems described herein may be embodied in avariety of other forms without departing from the spirit thereof. Theaccompanying claims and their equivalents are intended to cover suchforms or modifications as would fall within the scope and spirit of thesubject technology.

What is claimed is:
 1. An intraocular drainage device, comprising: aflexible main body comprising a step; a flow control device within theflexible main body operable to allow fluid flow through the flexiblemain body in a fluid flow direction; and a rigid top plate disposedwithin an opening in the flexible main body, wherein the rigid top platecomprises a top surface, a central portion, a pair of shelf membersdisposed on opposing sides of the central portion, and a step disposedbetween the pair of shelf members and the top surface, wherein the stepof the flexible main body conforms to the step of the rigid top plate.2. The intraocular drainage device of claim 1, wherein the flow controldevice comprises a valve formed in part by a flap portion of theflexible main body, and wherein the intraocular drainage device furthercomprises: a rigid bottom plate, each of the rigid top plate and therigid bottom plate being disposed in a respective opening on theflexible main body.
 3. The intraocular drainage device of claim 1,wherein the flexible main body comprises a top surface and a flap thatforms a portion of the flow control device, wherein the opening in theflexible main body is disposed in the top surface and bounded byopposing lobes.
 4. The intraocular drainage device of claim 1, whereinthe pair of shelf members are separated by a gap at a front end of therigid top plate configured to allow fluid to flow therethrough.
 5. Theintraocular drainage device of claim 4, wherein the pair of shelfmembers are further separated by a gap at a rear end of the rigid topplate larger than the gap at the front end.
 6. The intraocular drainagedevice of claim 4, further comprising a tube having a portion disposedin the gap at the front end of the rigid top plate.
 7. The intraoculardrainage device of claim 1, wherein flexible main body is a monolithicsilicone body.
 8. An intraocular drainage device, comprising: a mainbody configured to allow aqueous humor to flow therethrough, wherein themain body comprises a step; and a rigid top plate disposed within anopening in the main body, wherein the rigid top plate comprises a topsurface, a central portion, a pair of shelf members disposed on opposingsides of the central portion, and a step disposed between the pair ofshelf members and the top surface, wherein the step of the main bodyconforms to the step on the rigid top plate.
 9. The intraocular drainagedevice of claim 8, further comprising: a flow-restricting flap disposedwithin the main body; and a rigid bottom plate disposed in anotheropening on the main body.
 10. The intraocular drainage device of claim8, wherein the main body comprises a top surface, wherein the opening inthe main body is disposed in the top surface and bounded by opposinglobes that each bear against the rigid top plate.
 11. The intraoculardrainage device of claim 8, wherein the pair of shelf members areseparated by a gap at a front end of the rigid top plate.
 12. Theintraocular drainage device of claim 11, wherein the pair of shelfmembers are further separated by a gap at a rear end of the rigid topplate larger than the gap at the front end.
 13. The intraocular drainagedevice of claim 11, further comprising a tube having a portion disposedin the gap at the front end of the rigid top plate.
 14. The intraoculardrainage device of claim 8, wherein main body is a monolithic flexiblebody made from a biocompatible material.
 15. The intraocular drainagedevice of claim 8, wherein main body is a rigid main body.
 16. Anintraocular drainage device, comprising: a flexible main body having aflap and a top surface, the top surface having an opening bounded byopposing lobes; a rigid bottom plate having a portion configured tocontact a corresponding portion of the flap; and a rigid top platehaving a top surface disposed in the opening in the top surface of theflexible main body, wherein a portion of the top surface of the rigidtop plate forms a portion of a top surface of the intraocular drainagedevice, and wherein the opposing lobes each bear against another portionof the top surface of the rigid top plate.
 17. The intraocular drainagedevice of claim 16, further comprising: a tube having a proximal enddisposed between the flap and the rigid bottom plate, wherein thecorresponding portion of the flap is configured to separate from theportion of the rigid bottom plate responsive to a pressure of aqueoushumor received from the tube to allow fluid flow through the flexiblemain body in a fluid flow direction.
 18. The intraocular drainage deviceof claim 17, wherein the tube comprises a distal end configured to bedisposed within an anterior chamber of an eye of a patient.
 19. Theintraocular drainage device of claim 16, wherein the rigid top platecomprises a pair of shelf members and a step disposed between the pairof shelf members and the top surface of the rigid top plate, and whereinthe flexible main body includes a step that conforms to the step on therigid top plate.
 20. The intraocular drainage device of claim 16,wherein the flexible main body comprises a monolithic silicone body.